	US 12,268,658 B2
	Dosage regime with esketamine for treating major depressive disorder
Johanna Schumann, Jerusalem (IL); and Dorit Mimrod, Jerusalem (IL)
Assigned to CLEXIO BIOSCIENCES LTD., Yokne'am (IL)
Appl. No. 17/789,631
Filed by CLEXIO BIOSCIENCES LTD., Jerusalem (IL)
PCT Filed Dec. 29, 2020, PCT No. PCT/IB2020/062507 § 371(c)(1), (2) Date Jun. 28, 2022, PCT Pub. No. WO2021/137147, PCT Pub. Date Jul. 8, 2021.
Claims priority of provisional application 62/954,779, filed on Dec. 30, 2019.
Prior Publication US 2023/0063459 A1, Mar. 2, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/135 (2006.01); A61K 31/137 (2006.01); A61K 31/138 (2006.01); A61K 31/15 (2006.01); A61K 31/343 (2006.01); A61K 31/381 (2006.01); A61K 31/4525 (2006.01); A61K 45/06 (2006.01); A61P 25/24 (2006.01)

CPC A61K 31/135 (2013.01) [A61K 31/137 (2013.01); A61K 31/138 (2013.01); A61K 31/15 (2013.01); A61K 31/343 (2013.01); A61K 31/381 (2013.01); A61K 31/4525 (2013.01); A61K 45/06 (2013.01); A61P 25/24 (2018.01)]

19 Claims

1. A method of treating major depressive disorder (MDD) in a human patient in need thereof with a once daily esketamine administration comprising orally administering to said patient, once every 24 hours, an immediate release oral dosage form comprising between about 41 mg and about 80 mg of esketamine over a treatment regimen of at least 28 days and wherein the esketamine C_maxof said administration is 30 ng/ml or less and/or the esketamine AUC_0-tof said administration is 60 ng*h/ml or less.